clinical trial software - features

Clinical trial software - features

The CRFweb HTML Editor suite is easy to use and intuitive. Designed to have the look, feel and functionality of typical office software suites, CRFweb gives instant familiarity. Only rudimentary training is required to understand the process. It’s genuinely DIY, but support is always available if required.

Create an eCRF

Just click on the 'create new CRF' icon to get up and running. This takes you through the logical steps to create your study. After entering the basic study information, you can design the page layout using simple office style formatting, or HTML coding if you desire.

Study design

Next you add and edit the key components of your study (eg. Medicine log or incident log) from our CRF log. The system structures all interview questions on a visit by visit basis, so the next step is to set up and design those visits . All questions related to a specific visit to the subject are set here and can be grouped into multiple sections to accommodate complex or multiple questions as appropriate. You can create your own questions or add them from a template or question bank. The system now offers multi-language capability, which can be set at the design stage.

Once your first CRF has been set up, you can use it as a template for future work and edit as required.

Defining access roles

CRFweb follows a dynamic approach to role based access controls. You determine the number of roles and their defined capabilities when setting up a study; common default roles, such as Investigator, Data Manager, Monitor will be in your company settings, however you can rename, add and define roles to meet a studies specific needs.

All roles that have an active participation in a CRF are assigned to that particular CRF, while system-wide users can have for example a ‘view reports only' access not assigned to specific CRFs. Individual users can also have multiple roles within their profile as required. In short, you have complete control of who has access to what.

Input data

Once you have your CRF set up, both you and your investigators will be able to input data according to the designated access levels you’ve assigned. All users can access from desktop, laptop or tablet as required.

Everything is ergonomically designed for ease of use. From the dashboard, just click on the ‘input data to a CRF’ icon and away you go. It’s just one click to the main areas of the process and one click back again. Users are taken through a step by step process for data entry and you can save and review saved work as you go.

You can add a new subject here and/or allocate a subject to a CRF. The Colour coded process bar gives each user a clear overview of each subject’s status within a study. When with a subject, the investigator simply goes to the appropriate visit and all the information required, and questions to ask, are simply and clearly laid out.

In the example below we can see the the subjects, ID, and number of visits (in this case 3) with colour coded status.

The 'Manage a CRF' section is the trial manager’s control centre. Here you can monitor the progress of all your CRF’s. You can edit a CRF, adding saved questions, sections and Logs from your online library if required. It also allows you to collect data, Verify Data, Confirm Data and monitor Subjects, Investigators and CRF progress - all from one screen.

From the 'Manage a CRF' section you can also output reports: All data is mapped using CDISC’s ODM model and reporting outputs offer direct XML ODM Transactional and Snapshot outputs. Alternatively, data can be translated to a SAS Export file or simply outputted directly to an excel spreadsheet. An audit trail provides reporting capability on a specific question or visit level. Results can be filtered to focus the information as required.

Security

We take security very seriously. To give your confidential data maximum possible security, we use the latest SSL_256-bit encryption, and access is continually monitored. We use servers based in Europe & the US for proven reliability.

Compliance

CRFweb Complies with FDA 21 CFR Part 11 regulations and was most recently independently audited in 2017. Follow this linkfor further details of the audit. It also meets GCP (Good Clinical Practice) standards. We have utilised the CDISC ODM (Operational Data Model) as our default coding standard for all aspects of a clinical trial; both Transactional and Snapshot data extracts are available for all datasets. Snapshot and Transactional ODM files can be exported as either XML or .xls files or exported as a SAS Xport file. Our new offline data collection app, allows data to be collected safely offline and automatically synced when a secure connection is available.

ePRO Module

CRFweb now features a fully integrated ePRO interface, where subjects can answer questionnaires without risk of accessing other functionality or data. Site staff can easily initiate a subject session to allow the subject to answer at the clinic (e.g. using a tablet), or the subject can log in from home with a unique username and password. Features summary:

Multilingual patient questionnaires/surveys

Easy switch to subject entry mode

Subject login from home

Data entry on tablet

No risk of subject accessing other functionality or data

Scheduling and reminder facility

CRFweb is a Clindox application

CRFweb is fully compliant with and a Gold Member of the Clinical Data Interchange Standards Consortium